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      Efficacy and Safety of Lopinavir/Ritonavir for Treatment of COVID-19: A Systematic Review and Meta-Analysis

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          Abstract

          (Background) Lopinavir-ritonavir (LPV/RTV) is a human immunodeficiency virus (HIV) antiviral combination that has been considered for the treatment of COVID-19 disease. (Aim) This systematic review aimed to assess the efficacy and safety of LPV/RTV in COVID-19 patients in the published research. (Methods) A protocol was developed based on the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) statement. Articles were selected for review from 8 electronic databases. This review evaluated the effects of LPV/RTV alone or in combination with standard care ± interferons/antiviral treatments compared to other therapies, regarding duration of hospital stay, risk of progressing to invasive mechanical, time to virological cure and body temperature normalization, cough relief, radiological progression, mortality and safety. (Results) A consensus was reached to select 32 articles for full-text screening; only 14 articles comprising 9036 patients were included in this study; and eight of these were included for meta-analysis. Most of these studies did not report positive clinical outcomes with LPV/RTV treatment. In terms of virological cure, three studies reported less time in days to achieve a virological cure for LPV/RTV arm relative to no antiviral treatment (−0.81 day; 95% confidence interval (CI), −4.44 to 2.81; p = 0.007, I 2 = 80%). However, the overall effect was not significant ( p = 0.66). When comparing the LPV/RTV arm to umifenovir arm, a favorable affect was observed for umifenovir arm, but not statically significant ( p = 0.09). In terms of time to body normalization and cough relief, no favorable effects of LPV/RTV versus umifenovir were observed. The largest trials (RECOVERY and SOLIDARITY) have shown that LPV/RTV failed to reduce mortality, initiation of invasive mechanical ventilation or hospitalization duration. Adverse events were reported most frequently for LPV/RTV ( n = 84) relative to other antivirals and no antiviral treatments. (Conclusions) This review did not reveal any significant advantage in efficacy of LPV/RTV for the treatment of COVID-19 over standard care, no antivirals or other antiviral treatments. This result might not reflect the actual evidence.

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          RoB 2: a revised tool for assessing risk of bias in randomised trials

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            ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions

            Non-randomised studies of the effects of interventions are critical to many areas of healthcare evaluation, but their results may be biased. It is therefore important to understand and appraise their strengths and weaknesses. We developed ROBINS-I (“Risk Of Bias In Non-randomised Studies - of Interventions”), a new tool for evaluating risk of bias in estimates of the comparative effectiveness (harm or benefit) of interventions from studies that did not use randomisation to allocate units (individuals or clusters of individuals) to comparison groups. The tool will be particularly useful to those undertaking systematic reviews that include non-randomised studies.
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              A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19

              Abstract Background No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2. Methods We conducted a randomized, controlled, open-label trial involving hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2) to the fraction of inspired oxygen (Fio 2) of less than 300 mm Hg. Patients were randomly assigned in a 1:1 ratio to receive either lopinavir–ritonavir (400 mg and 100 mg, respectively) twice a day for 14 days, in addition to standard care, or standard care alone. The primary end point was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first. Results A total of 199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the lopinavir–ritonavir group, and 100 to the standard-care group. Treatment with lopinavir–ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72). Mortality at 28 days was similar in the lopinavir–ritonavir group and the standard-care group (19.2% vs. 25.0%; difference, −5.8 percentage points; 95% CI, −17.3 to 5.7). The percentages of patients with detectable viral RNA at various time points were similar. In a modified intention-to-treat analysis, lopinavir–ritonavir led to a median time to clinical improvement that was shorter by 1 day than that observed with standard care (hazard ratio, 1.39; 95% CI, 1.00 to 1.91). Gastrointestinal adverse events were more common in the lopinavir–ritonavir group, but serious adverse events were more common in the standard-care group. Lopinavir–ritonavir treatment was stopped early in 13 patients (13.8%) because of adverse events. Conclusions In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir–ritonavir treatment beyond standard care. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit. (Funded by Major Projects of National Science and Technology on New Drug Creation and Development and others; Chinese Clinical Trial Register number, ChiCTR2000029308.)
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                Author and article information

                Journal
                Trop Med Infect Dis
                Trop Med Infect Dis
                tropicalmed
                Tropical Medicine and Infectious Disease
                MDPI
                2414-6366
                28 November 2020
                December 2020
                : 5
                : 4
                : 180
                Affiliations
                [1 ]Administration of Pharmaceutical Care, Ministry of Health, Al-Ahsa 31982, Saudi Arabia
                [2 ]Research Center, Almoosa Specialist Hospital, Al-Ahsa 31982, Saudi Arabia; abbas.almutair@ 123456almoosahospital.com.sa
                [3 ]Department of Pediatrics, College of Medicine, King Faisal University, Al-Ahsa 31982, Saudi Arabia; dr_z.alawi@ 123456hotmail.com
                [4 ]Administration of Supply and Shared Services, Ministry of Health, Riyadh 11461, Saudi Arabia; nalhmeed@ 123456moh.gov.sa
                [5 ]Research Center, Dr. Sulaiman Al Habib Medical Group, Riyadh 11461, Saudi Arabia; ar-zia@ 123456hotmail.com
                [6 ]Department of Pharmacology, College of Medicine, University of Jeddah, Jeddah 21442, Saudi Arabia; mtobaiqy@ 123456uj.edu.sa
                Author notes
                [* ]Correspondence: saalhumaid@ 123456moh.gov.sa ; Tel.: +966-561-522-581
                Author information
                https://orcid.org/0000-0003-4552-4513
                https://orcid.org/0000-0002-9471-2767
                https://orcid.org/0000-0003-0137-9633
                https://orcid.org/0000-0002-4292-0900
                Article
                tropicalmed-05-00180
                10.3390/tropicalmed5040180
                7768433
                33260553
                da0c0c5b-c201-40ae-9653-f2a2c45c6a97
                © 2020 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 22 October 2020
                : 26 November 2020
                Categories
                Review

                covid-19,efficacy,safety,kaletra,lopinavir/ritonavir,meta-analysis

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